药品上市许可持有人制度相关法律问题的研究

Research on Legal Issues Related to Drug Marketing Authorization Holder System

在药品上市许可持有人(MAH)制度下,上市许可持有人和生产许可持有人不再受约束,上市许可持有人可自行生产药品,也可委托其他具备条件的药品生产企业生产药品,但与之相配套的法律体系尚不完善。2019年12月1日施行的新《药品管理法》对MAH申请主体、药品上市许可转让条件及药品上市许可共同持有等问题均未作正面评价,未达到MAH制度加快创新药上市、刺激新药研发的目的。该研究介绍了药品上市许可持有人制度相关法律问题,借鉴国外MAH制度先进经验,为解决我国MAH制度下相关法律问题提供可行性建议。

Under the MAH system,marketing authorization holders and production license holders are no longer bound.Marketing Authorization Holders can produce drugs by themselves or entrust other qualified drug manufacturers to produce drugs.However,the supporting legal system is imperfect.The new"Drug Administration Law",which came into effect on December 1,2019,has not made a positive evaluation on the subject of MAH applicants,the conditions for the transfer of drug marketing licenses,and the joint holding of drug marketing licenses,which does not meet the MAH system's purpose of accelerating the launch of innovative drugs and stimulate the research and development of new drugs.The article studies the legal issues related to the marketing authorization holder system and drawing on the advanced experience of foreign MAH systems,provide feasible suggestions for solving relevant legal issues under my country's MAH system.